adminrd, Author at RegDesk

Apr 26, 2024

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 8-10

The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Types and Classes

Apr 26, 2024

Australia

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Types and Classes

The new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from a regulatory standpoint.

MDCG Guidance on Qualification and Classification of Annex XVI Products: Overview and Qualification

Apr 12, 2024

EU

MDCG Guidance on Qualification and Classification of Annex XVI Products: Overview and Qualification

The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.

HSA Guidance on Medical Device Product Registration: Specific Aspects

Apr 12, 2024

HSA

HSA Guidance on Medical Device Product Registration: Specific Aspects

The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.

SFDA Guidance on Surgical Sutures: Overview

Apr 12, 2024

Saudi Arabia

SFDA Guidance on Surgical Sutures: Overview

The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.

RegDesk Regulatory Roundup

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 8-10

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Types and Classes

MDCG Guidance on Qualification and Classification of Annex XVI Products: Overview and Qualification

HSA Guidance on Medical Device Product Registration: Specific Aspects

SFDA Guidance on Surgical Sutures: Overview

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